Product Name

Cabergoline

Batch No

20230303

Mfg.Date

2023-03-03

Annalysis Date

2023-03-03

Quantity

500mg

CAS No

81409-90-7

Exp.Date

2025-03-02

Storage

Preserve in tight containers.Shipment at normal temperature.For long time storage at +2℃~+8℃,must be tightly sealed,protect from air.

ITEM AND RESULT

Appearance

White or almost white crystalline powder

Complies

Identification

1.IR complies

Complies

2.X-Ray complies

Complies

3.HPLC complies

Complies

Loss on drying

≤0.5%

0.12%

Optical rotation

-83.0°~ -77.0°

-80.0°

Relate substances

1.Impurity A≤0.15%

0.02%

2.Impurity B≤0.10%

0.02%

3.Impurity C≤0.30%

0.05%

4.Impurity D≤0.10%

0.02%

5.Other individual impurities ≤0.10%

0.02%

6.Total impurities ≤0.80%

0.12%

Residual Solvents

1.Dichloromethane ≤100ppm

30ppm

2.Acetone ≤200ppm

20ppm

3.Ter-butylmethylether≤200ppm

10ppm

4.Xylene≤1500ppm

80ppm

5.Heptane≤1000ppm

30ppm

Residue on ignition

≤0.10%

0.03%

Heavy metals

≤20ppm

1ppm

Particle size

90% of particle size ≤80um

Complies

Bulk density

0.20~0.35g/cm3

0.33g/cm3

Assay (on dry matter)

98.0%~102.0%

100.2%

conclusion

Complies with in EP7.0/USP38 Standard.